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Open-Label "Compassionate" Use Study of Spiramycin for the Treatment of Diarrhea Due to Chronic Cryptosporidiosis in Immunocompromised Patients

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ClinicalTrials.gov Identifier: NCT00002062
Recruitment Status : Completed
First Posted : August 31, 2001
Last Update Posted : June 24, 2005
Sponsor:
Information provided by:

Study Description
Brief Summary:
This protocol provides for the availability of spiramycin under compassionate-use conditions for the treatment of chronic diarrhea due to cryptosporidium in patients with a compromised immune system, thus deriving additional information regarding its safety and efficacy profile.

Condition or disease Intervention/treatment
Cryptosporidiosis HIV Infections Drug: Spiramycin

Study Design

Study Type : Interventional  (Clinical Trial)
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open-Label "Compassionate" Use Study of Spiramycin for the Treatment of Diarrhea Due to Chronic Cryptosporidiosis in Immunocompromised Patients

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions


Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Exclusion Criteria

Co-existing Condition:

Patients with known sensitivity to macrolide antibiotics are excluded. Consideration must be given to the fact that spiramycin is a macrolide antibiotic and, therefore, may have the potential to induce hepatotoxicity.

  • Patients with a compromised immune system may have hepatic abnormalities or even hepatitis. If the benefit-to-risk ratio does not favor the use of spiramycin, the patients must be excluded from the study.

Concurrent Medication:

Excluded:

  • Other investigational drugs.

Patients with known sensitivity to macrolide antibiotics are excluded. Consideration must be given to the fact that spiramycin is a macrolide antibiotic and, therefore, may have the potential to induce hepatotoxicity.

  • Patients with a compromised immune system may have hepatic abnormalities or even hepatitis. If the benefit-to-risk ratio does not favor the use of spiramycin, the patients must be excluded from the study.

Prior Medication:

Excluded within 7 days of study entry:

  • Other investigational drugs.

Diagnosis of chronic diarrhea due to cryptosporidiosis and a compromised immune system but not limited to patients with AIDS.

  • Patients receiving chemotherapy for a malignancy.
  • Patients who are iatrogenically immune-suppressed following organ transplantation.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00002062


Locations
United States, Pennsylvania
Rhone - Poulenc Rorer Pharmaceuticals
Horsham, Pennsylvania, United States, 19044
Sponsors and Collaborators
Rhone-Poulenc Rorer
More Information

ClinicalTrials.gov Identifier: NCT00002062     History of Changes
Other Study ID Numbers: 011A
CCA 901
First Posted: August 31, 2001    Key Record Dates
Last Update Posted: June 24, 2005
Last Verified: October 1991

Keywords provided by NIH AIDS Clinical Trials Information Service:
Spiramycin
AIDS-Related Opportunistic Infections
Immune Tolerance
Cryptosporidiosis
Diarrhea
Drugs, Investigational
Acquired Immunodeficiency Syndrome

Additional relevant MeSH terms:
HIV Infections
Diarrhea
Cryptosporidiosis
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Signs and Symptoms, Digestive
Signs and Symptoms
Intestinal Diseases, Parasitic
Parasitic Diseases
Protozoan Infections, Animal
Parasitic Diseases, Animal
Coccidiosis
Protozoan Infections
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Spiramycin
Anti-Bacterial Agents
Anti-Infective Agents
Coccidiostats
Antiprotozoal Agents
Antiparasitic Agents